Priority Lists
Protocol Posting of
Activations
Activation
Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma
| Study Coordinator(s) | Kim A. Margolin, M.D., Thomas Gajewski, M.D., Ph.D |
| Participants | Members, Medical Oncologists, Pathologists, NCORP, Affiliates |
Closures
Permanent Closure effective 10/27/10
Phase III Randomized Study of Four Weeks of High Dose IFN-alpha2b in Stage T2b N0, T3a-b N0, T4a-b N0, and T1-4, N1a, 2a, 3(Microscopic) Melanoma
| Action Codes | IP, FBR |
| Study Coordinator(s) | Lawrence E. Flaherty, M.D. |
| Participants | CTSU |
| Closure Date | 2010-10-27 |
Permanent Closure effective 11/1/10
Myeloma Specimen Repository Protocol, Ancillary
| Action Codes | ER |
| Study Coordinator(s) | Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Amendments, Revisions, Memoranda
Revision #4
An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)
| Action Codes | ER |
| Study Coordinator(s) | Anjali S. Advani, M.D., Frederick R. Appelbaum, M.D. |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, Pathologists |
Memorandum - Adverse Event Reporting Update
A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy Versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-Myeloablative Allogeneic Stem Cell Transplant for Patients with Multiple Myeloma
| Action Codes | NR |
| Study Coordinator(s) | George Somlo, M.D. |
| Participants | Limited Institutions: BMT Members |
Revision #3
Phase III Rituxan/BEAM vs. Bexxar/BEAM with Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin’s Lymphoma
| Action Codes | ER |
| Study Coordinator(s) | Oliver W. Press, M.D.,Ph.D. |
| Participants | Limited Institutions: BMT Members |
Memorandum - CTEP withdrawn IND for Tirapazamine
Randomized Phase III Trial of Carboplatin and Paclitaxel plus Tirapazamine versus Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer Cisplatin, Paclitaxel, Tirapazamine vs. Cisplatin, Paclitaxel Specimen submission per S9925
| Action Codes | ER |
| Study Coordinator(s) | Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, EPP, CTSU |
Memorandum - CTEP withdrawn IND for Tirapazamine
A Phase I Study of Tirapazamine/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Janice Ryu, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists |
Memorandum - CTEP withdrawn IND for Tirapazamine
A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D., Zelanna Goldberg, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists |
Revision #9
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
| Action Codes | ER |
| Study Coordinator(s) | Halle C.F. Moore, M.D., Silvana Martino, D.O. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CALGB, ECOG, IBCSG |
Memorandum - Clodronate Safety Reports
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
| Action Codes | ER |
| Study Coordinator(s) | Julie R. Gralow, M.D., Robert B. Livingston, M.D., Daniel F. Hayes, M.D., Dawn Hershman, M.D., M.S., Alison T. Stopeck, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CTSU |
Memorandum – CCI-779 Safety Report
A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) with Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma
| Action Codes | ER |
| Study Coordinator(s) | Kim A. Margolin, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D., Lawrence E. Flaherty, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, ECOG |
Memorandum - Bevacizumab Safety Reports
A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors
| Action Codes | ER |
| Study Coordinator(s) | Charles D. Blanke, M.D., Michael C. Heinrich, M.D., Christopher Corless, M.D., Ph.D |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - AZD2171 Safety Report
A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
| Action Codes | ER |
| Study Coordinator(s) | Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum - Bevacizumab Safety Reports
Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
| Action Codes | ER |
| Study Coordinator(s) | James C. Yao, M.D., Larry K. Kvols, M.D., Cesar A. Moran, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - Bevacizumab Safety Reports
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Antoinette J. Wozniak, M.D., Charles R. Thomas Jr., M.D., Karen Kelly, M.D., Laurie E. Gaspar, M.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum - Biologics Holiday Closures
A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
| Action Codes | NR |
| Study Coordinator(s) | Jeffrey E. Lancet, M.D., Rami Komrokji, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
| Participants | NCORP, Affiliates, Medical Oncologists, Members, Pathologists, CTSU |
Memorandum - Bevacizumab Safety Reports
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bevacizumab Safety Reports
Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with either FOLFOX, OPTIMOX, or XELOX
| Action Codes | ER |
| Study Coordinator(s) | Philip Gold, M.D., Anthony Shields, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - Bevacizumab Safety Reports
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features
| Action Codes | ER, NR |
| Study Coordinator(s) | Howard (Jack) West, M.D., Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Biologics Holiday Closures
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features
| Action Codes | ER, NR |
| Study Coordinator(s) | Howard (Jack) West, M.D., Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bevacizumab Safety Reports
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas
| Action Codes | ER |
| Study Coordinator(s) | Howard (Jack) West, M.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Biologics Holiday Closures
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas
| Action Codes | ER |
| Study Coordinator(s) | Howard (Jack) West, M.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Biologics Holiday Closures
A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performance Status 2 (PS-2) Selected by Serum Proteomics
| Action Codes | NR |
| Study Coordinator(s) | Primo N. Lara, Jr., M.D., Paul J. Hesketh, M.D., Philip C. Mack, Ph.D., Fred R. Hirsch, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Affiliates |
Memorandum - IMC-A12 Safety Reports
A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First Line Treatment in Patients with Metastatic Pancreatic Cancer
| Action Codes | ER |
| Study Coordinator(s) | Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum 1 of 2 - Bevacizumab Safety Reports
A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
| Action Codes | ER, NR |
| Study Coordinator(s) | Zeina Nahleh, M.D., Daniel F. Hayes, M.D., Anne F. Schott, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, US INSTITUTIONS ONLY |
Memorandum 2 of 2 - Biologics Holiday Schedule
A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
| Action Codes | ER, NR |
| Study Coordinator(s) | Zeina Nahleh, M.D., Daniel F. Hayes, M.D., Anne F. Schott, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, US INSTITUTIONS ONLY |
Memorandum - AVE0005 Safety Reports
A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)
| Action Codes | ER |
| Study Coordinator(s) | Jeffrey W. Allen, M.D., Karen Kelly, M.D., Philip C. Mack, Ph.D., Shirish M. Gadgeel, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Biologics Holiday Schedule
Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel plus Vandetanib in Patients with Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
| Action Codes | NR |
| Study Coordinator(s) | Robert L. Coleman, M.D., Anil K. Sood, M.D. |
| Participants | Members, Affiliates, NCORP, Medical Oncologists |
Memorandum - AZD2171 Safety Report
A Phase I / Randomized Phase II Study of Cediranib (NSC #732208) Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma
| Action Codes | ER |
| Study Coordinator(s) | Anne Tsao, M.D., Nicholas J. Vogelzang, M.D., Ignacio I. Wistuba, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Other New Items
- IP - Pts Must Be Informed
- AC - Consent Must Be Amended
- CBR - No Registration Allowed until IRB Review
- RC - Formal Re-consent Required
- FBR - Full Board Review Required
- ER - Expedited Review Acceptable
- NR - No IRB Review Required